Intracranial Surgery
Conditions
Brief summary
This is a prospective, randomized controlled clinical trial to evaluate the efficacy and safety of intravenous patient controlled analgesia (IVPCA) in patients following major intracranial surgery (e.g. brain tumors, vascular surgery). We will compare pain, opioid consumption, costs, sedation level, length of hospital stay, patient satisfaction, and complications in patients randomized to receive either pro re nata (PRN) or IVPCA opioids. We hypothesize that IVPCA will be more efficacious than PRN opioids in the treatment of postoperative without an increased incidence of adverse effects.
Interventions
DRUGPCA fentanyl
PCA fentanyl 0.5 ug/kg with a dosing interval (lockout) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
DRUGPRN fentanyl
IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults undergoing intracranial surgery
Exclusion criteria
* Patient refusal * Pregnancy * Aphasia * Respiratory failure * Allergy/intolerance to fentanyl * Opioids use * History of opioid-dependent pain, * Patient has been in an investigational drug trial (except chemotherapy) in the month preceding the day of enrollment * Mental or physical limitations that would prevent patient assessment or PCA use * Chronic painful conditions unrelated to the reason for surgery, * Clinically significant respiratory disease that required supplemental oxygen or ventilatory support such as use of mechanical ventilation or positive pressure ventilation * Patient is unable to initiate a bolus dose of IVPCA fentanyl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hourly Pain Scores | Up to 16 hours | Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fentanyl Consumption | Up to 16 hours | the amount of fentanyl is that administered in response to corresponding rest pain levels. Thus, the 0 hour indicates the amount of fentanyl administered from the time of admission until the end of the first hour. Also note that once pain assessments are made every other hour (e.g., 10, 12, 14, and 16), the analgesic totals indicated are for the corresponding 2-hour period after the pain assessment, and were halved to estimate the hourly rate of analgesic consumption. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Supratentorial PCA Fentanyl PCA fentanyl: Patient controlled analgesia (PC fentanyl 0.5 ug/kg with a dosing interval (lockout) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted | 29 |
| Supratentorial PRN Fentanyl PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes pro re nata (PRN) (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU)) | 35 |
| Infratentorial PCA Fentanyl PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (lockout) of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted | 31 |
| Infratentorial PRN Fentanyl PRN fentanyl: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU)) | 34 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Inability to trigger PCA | 2 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 2 | 1 | 6 | 4 |
| Overall Study | Unanticipated Neurosurgical Complication | 6 | 3 | 3 | 2 |
| Overall Study | Unrecognized exclusion criteria met | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Supratentorial PCA Fentanyl | Supratentorial PRN Fentanyl | Infratentorial PCA Fentanyl | Infratentorial PRN Fentanyl | Total |
|---|---|---|---|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 11.9 | 47.8 years STANDARD_DEVIATION 15 | 45.4 years STANDARD_DEVIATION 14.6 | 41.4 years STANDARD_DEVIATION 11.1 | 45.6 years STANDARD_DEVIATION 13.2 |
| Region of Enrollment United States | 29 Participants | 35 Participants | 31 Participants | 34 Participants | 129 Participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 20 Participants | 21 Participants | 76 Participants |
| Sex: Female, Male Male | 11 Participants | 18 Participants | 11 Participants | 13 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 35 | 0 / 31 | 0 / 34 |
| other Total, other adverse events | 0 / 29 | 0 / 35 | 0 / 31 | 0 / 34 |
| serious Total, serious adverse events | 0 / 29 | 0 / 35 | 0 / 31 | 0 / 34 |
Outcome results
Primary
Hourly Pain Scores
Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain)
Time frame: Up to 16 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supratentorial PCA Fentanyl | Hourly Pain Scores | 2.5 units on a scale | Standard Deviation 2 |
| Supratentorial PRN Fentanyl | Hourly Pain Scores | 3.6 units on a scale | Standard Deviation 2.1 |
| Infratentorial PCA Fentanyl | Hourly Pain Scores | 3.7 units on a scale | Standard Deviation 1.9 |
| Infratentorial PRN Fentanyl | Hourly Pain Scores | 5.2 units on a scale | Standard Deviation 1.9 |
Secondary
Fentanyl Consumption
the amount of fentanyl is that administered in response to corresponding rest pain levels. Thus, the 0 hour indicates the amount of fentanyl administered from the time of admission until the end of the first hour. Also note that once pain assessments are made every other hour (e.g., 10, 12, 14, and 16), the analgesic totals indicated are for the corresponding 2-hour period after the pain assessment, and were halved to estimate the hourly rate of analgesic consumption.
Time frame: Up to 16 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supratentorial PCA Fentanyl | Fentanyl Consumption | 44.1 mcg/hour | Standard Deviation 34.5 |
| Supratentorial PRN Fentanyl | Fentanyl Consumption | 23.6 mcg/hour | Standard Deviation 23.7 |
| Infratentorial PCA Fentanyl | Fentanyl Consumption | 54.8 mcg/hour | Standard Deviation 34.8 |
| Infratentorial PRN Fentanyl | Fentanyl Consumption | 29.9 mcg/hour | Standard Deviation 16.4 |